Ulcerative Colitis Clinical Trial
Official title:
Investigation of Vascular Endothelial Dysfunction, Thromboembolism and Structural Arterial Disease in Paediatric and Adolescent Inflammatory Bowel Disease (IBD)
Verified date | February 2017 |
Source | Great Ormond Street Hospital for Children NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory
conditions acquired due to genetic susceptibility and/or environmental triggers. The disease
manifestations are being increasingly seen in young children and the life-long debilitation
has a severe effect on quality of life. Limited evidence suggests, although rare, in some
young IBD individuals vascular complications may ensue. This leads to increased risk of
vascular problems such as thrombosis, arterial disease and stroke.
In the present project we aim to study and highlight potential vascular changes in young
Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender
matched controls. Vasculature will be measured in multiple ways including blood analysis in
the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound
arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of
vascular dysfunction as this will open new avenues for early therapeutic intervention.
Status | Completed |
Enrollment | 63 |
Est. completion date | January 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of Inflammatory bowel disease (IBD arm) - Aged between 8 years and 18 years at recruitment (both arms) Exclusion Criteria: - Clinical diagnosis of Inflammatory Bowel Disease (Control arm) - Diagnosis of any other chronic inflammatory condition |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormond Street Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Great Ormond Street Hospital for Children NHS Foundation Trust | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Carotid-Femoral Pulse Wave Velocity (PWV) | Pulse wave velocity is a measure of arterial stiffness, and correlates with cardiovascular events and all-cause mortality. | Once, upon recruitment | |
Secondary | Plasma Microparticle (MP) number | Plasma microparticles will be isolated and enumerated by flow cytometry | Once, upon recruitment | |
Secondary | Carotid Intima Media Thickness | The thickness of the carotid tunica intima and tunica media will be assessed by ultrasound. This thickness correlates with atherosclerosis. | Once, upon recruitment | |
Secondary | Plasma Microparticle (MP) pro-thrombotic potential | Plasma microparticles will be isolated and their pro-thrombotic potential will be assessed by calibrated automated thrombogram (CAT). | Once, upon recruitment | |
Secondary | Circulating endothelial cells (CEC)s enumeration | Circulating endothelial cells enumerated from whole blood, as a marker for endothelial dysfunction. | Once, upon recruitment | |
Secondary | Plasma C-reactive protein (CRP) level | Once, upon recruitment | ||
Secondary | Plasma serum amyloid A (SAA) level | Once, upon recruitment | ||
Secondary | Plasma Tumour Necrosis Factor Alpha (TNF-a) level | Once, upon recruitment | ||
Secondary | Plasma interleukin 1 alpha (IL-1a) level | Once, upon recruitment | ||
Secondary | Plasma interleukin 1 beta (IL-1b) level | Once, upon recruitment | ||
Secondary | Plasma interleukin 6 (IL-6) level | Once, upon recruitment | ||
Secondary | Plasma Monocyte Chemotactic Protein 1 (MCP-1) level | Once, upon recruitment | ||
Secondary | Plasma Vascular Endothelial Growth Factor (VEGF) level | Once, upon recruitment | ||
Secondary | Plasma fasting lipid levels | Once, upon recruitment | ||
Secondary | Plasma angiopoietin 1/2 levels | Once, upon recruitment | ||
Secondary | Erythrocyte Sedimentation Rate | Once, upon recruitment | ||
Secondary | Plasma D-dimer level | Once, upon recruitment |
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